The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications for its AI Airlock pilot, offering innovators the chance to benefit from expert support and sandbox testing for medical devices using AI.
Launched in spring 2024, the AI Airlock program is described by the MHRA as “a proactive, collaborative, agile and novel approach to identify and address the challenges facing AI as a medical device (AIaMD)”.
The pilot phase is expected to last until April 2025, with applicants expected to be able to complete their tests within six months. The deadline for applications is October 7, 2024.
Potential candidates are invited to complete a application form designed to “gather information on AI medical devices (AIaMD) and prototypes and assess their suitability for the AI Airlock pilot”. The MHRA is seeking information on the regulatory challenge that innovators would like to address using the regulatory sandbox, a summary of the intended use of their proposed product and their estimated data access needs.
Applications will be evaluated based on their potential to provide benefit to patients, the innovative nature of the proposed product or concept, the regulatory challenge it presents, and the existence of a plan describing a clear challenge, high-level objectives, access to data and quality management systems.
In terms of outcomes, project reports will be completed by each project team, and a lessons learned report will be published to “inform future directions and implications for the regulatory framework”, as well as a programme evaluation report to share lessons learned from the regulatory sandbox approach.
To learn more about the AI Airlock driver, please click here.
Regulation and innovation in AI
A recent HTN Now roundtable in mid-August Participants discussed the outlook for AI, managing bias, deploying AI in the NHS and the potential for AI to support the shift from reactive to proactive care. Our panel included Puja Myles, Director of MHRA Clinical Practice Research Datalink, who said that “the AI revolution is going to be driven by data, and we are constantly being asked if our data is ready for AI.”
In August we also have I’ve been exploring some recent NHS updates who share insights into how AI tools are being used and tested, covering their use in identifying anomalies, predicting Alzheimer’s disease, managing waiting lists, and more. Two questions posed to our audience in the same month highlighted some of the biggest concerns about AI in healthcareand barriers to responsible AI, including transparency, fairness and regulation.
Just this month, New guidelines have been released by Health Level Seven International (HL7) on the lifecycle of artificial intelligence and machine learning data, intended as an “informational document” to help developers promote the use of standards to “improve the trust and quality of interoperable data used in AI models.”
Innovation in health and care
HTN roundtables in recent months have focused on innovation, with an event in August exploring innovation in primary careconsidering what this innovation looks like, digital and patient access, and the barriers for innovators. Same month saw us welcome experts from the primary care fieldwho presented a case study of innovation in a medical centre in the North East of England, specifically looking at patient experience, practice improvement and the future of innovation in primary care.
August also brought News of the launch of a partnership between the NHS Clinical Entrepreneurs Programme (CEP) and the Alzheimer’s Society developing the Dementia Innovators programme, a pilot project designed to explore ideas that could support dementia care with professionals inside and outside the NHS.
Innovation funding news for September so far includes Launch of new £250,000 fund for innovation and digital tools in wound care was announced, designed to improve outcomes for patients with chronic wounds by supporting the widespread adoption of digital wound management in community nursing. SBRI Healthcare also announced a new funding competition looking for “work-related digital innovations for people with mental health problems”, with a focus on helping people stay in work, return to work or overcoming barriers to entry into the labour market.
